Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572826
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock ENIGMA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A framEwork for aN InteGrated assessMent of cArdiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENIGMA
Brief Summary:
This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health PNRR-MCNT2-2023-12377767 Using the Altshock registry the largest multicentre Cardiogenic Shock CS registry in Italy which currently has registered more than 1000 CS patients across Italy we will recruit patients to 1 provide a granular assessment of post-acute phase programmes patients functional disability return to work and quality of life including specific reference to gender 2 implement specific pathways of care in the post-acute phase 3 provide a multidimensional assessment thus validating an innovative model in comparison with the traditional pathway defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory
Detailed Description:
Study Population The study will include all consecutive Cardiogenic Shock CS patients from the Altshock registry The primary outcome is all-cause death and readmission-free survival at 6 months and 1 year post-ICU discharge Secondary outcomes include functional recovery measured by illness severity using the Medical Research Council Scale and electromyography if needed disease-specific PROM Kansas City Cardiomyopathy Questionnaire and a chronic condition PROM Long-Term Conditions Questionnaire at 6 months
Sample Size An estimated cohort of 2000 CS patients with around 1240 survivors will be studied This sample allows us to detect a 10 difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not with 80 power and a 5 significance level
Validation and Assessment A mixed-method approach will validate the innovative care model incorporating clinical data health economics and professional perceptions Key performance indicators and a RACI matrix will guide the implementation with a focus on short- and long-term organizational impacts economic benefits and healthcare professional perceptions
Data Analysis Quantitative variables will be analyzed using standard statistical methods and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests Multivariable Cox models will assess the impact of post-acute care services on outcomes Economic analyses will involve cost-effectiveness and budget impact assessments
Rehabilitation Intervention Post-acute care including cardiac and neuromotor rehabilitation is critical for CS patients to prevent complications and rehospitalization The rehabilitation program will include respiratory physiotherapy muscle strengthening endurance training cardiovascular exercises and secondary prevention strategies Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES
Expected Outcomes The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care reducing mortality enhancing quality of life and proving the cost-effectiveness and sustainability of innovative care pathways
Sample Size An estimated cohort of 2000 CS patients with around 1240 survivors will be studied This sample allows us to detect a 10 difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not with 80 power and a 5 significance level
Validation and Assessment A mixed-method approach will validate the innovative care model incorporating clinical data health economics and professional perceptions Key performance indicators and a RACI matrix will guide the implementation with a focus on short- and long-term organizational impacts economic benefits and healthcare professional perceptions
Data Analysis Quantitative variables will be analyzed using standard statistical methods and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests Multivariable Cox models will assess the impact of post-acute care services on outcomes Economic analyses will involve cost-effectiveness and budget impact assessments
Rehabilitation Intervention Post-acute care including cardiac and neuromotor rehabilitation is critical for CS patients to prevent complications and rehospitalization The rehabilitation program will include respiratory physiotherapy muscle strengthening endurance training cardiovascular exercises and secondary prevention strategies Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES
Expected Outcomes The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care reducing mortality enhancing quality of life and proving the cost-effectiveness and sustainability of innovative care pathways
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None